PALO ALTO, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today that data related to the Company's Amyotrophic Lateral Sclerosis (ALS) drug candidate, AL-02, will be presented at the 18th International Symposium on ALS/MND which will be held on December 1-3, 2007, in Toronto, Canada. The poster presentation by Allitia DiBernardo, M.D. of Massachusetts General Hospital will discuss a pooled analysis of survival data from three randomized, placebo-controlled studies. Results suggest a trend towards increased survival in patients taking AL-02.
The combined analysis examined three trials and included a total of 386 patients. The three trials were conducted by the Northeast ALS Consortium (NEALS), Carolinas Medical Center and Utrecht University. The pooled analysis showed an increase of 1.47-fold in median survival compared to results in patients taking a placebo. Certain portions of these data were presented to the FDA and formed the basis for Avicena's intent to initiate a confirmatory Phase III trial in 2008. This study will evaluate AL-02's effect on the primary endpoint of median survival and secondary endpoints of ALS functional scores.
"These data points support AL-02's positive effect on the survival rate of ALS patients," stated Belinda Tsao-Nivaggioli, Chairman and C.E.O. of Avicena. "We are very encouraged by these results and we will continue to advance AL-02 towards commercialization, as well as our drug candidates for Parkinson's and Huntington's disease. AL-02 will be the Company's third late-stage drug candidate."
ALS is a neurodegenerative disease that attacks the motor neurons of the brain and spinal cord that are responsible for voluntary muscle movement. As these motor neurons degenerate, their ability to send impulses to the muscle fibers is compromised. With an incidence rate of approximately 1 in 10,000, ALS affects roughly 30,000 Americans at any given time. Each year, approximately 5,600 new cases of ALS are diagnosed. The two types of ALS are "sporadic ALS," which accounts for approximately 85% - 90% of all cases; and "familial ALS," which accounts for the remaining 10% - 15% of patients. A progressive degeneration of motor neurons eventually leads to neuron death resulting in the brain's inability to initiate or control muscle movement. Once a patient's muscles no longer receive the messages that they require to function, muscles begin to atrophy.
Avicena Group, Inc. is a Palo Alto, California based late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases. The Company's core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical program centers on rare neurological disorders (orphan diseases). Near term, the Company plans to initiate a confirmatory Phase III trial in ALS and a Phase III trial in Huntington's disease to accompany the ongoing NIH Phase III trial in Parkinson's disease. Avicena's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena's clinical programs are largely funded by government and non-profit organizations. Avicena presently derives revenue from the sale of proprietary dermaceutical ingredients to skin care manufacturers.
This release contains forward-looking statements that reflect, among other things, management's current expectations, plans and strategies, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. See "Risk Factors" under "Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operation" from our Annual Report on Form 10-KSB for the year ended December 31, 2006, and other descriptions in the Company's public filings with the Securities and Exchange Commission for a discussion of such risks, including the Company's need for additional funds, the Company's dependence on a limited number of therapeutic compounds, the stage of the products the Company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the Company's ability to avoid infringement of the patent rights of others, and the Company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. Avicena does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.
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